Drugs

FDA Cuts Sotrovimab EUA Regions

FDA says that sotrovimab is not authorized in HHS regions 5, 9, and 10 as of 3/30 because the Centers for Disease Control and Prevention says that the proportion of Covid-19 cases caused by the omicron BA.2 variant is above 50% in those regions. An agency statement says that under terms of the emergency use authorization, sotrovimab is authorized to treat mild-to-moderate Covid-19 in adults and certain pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe Covid-19, including hospitalization or death.

The authorization was updated 2/23 to clarify that sotrovimab is not authorized for treating mild-to-moderate Covid-19 in geographic regions where the infection is likely to have been caused by a variant that is not susceptible to the treatment. HHS regions 1 and 2 were taken off the authorized list as of 3/25.

The therapy remains authorized in the remaining HHS regions where the CDC estimates that the proportion of the omicron BA.2 variant remains below 50%. FDA says it will continue to monitor BA.2 in all regions and may revise the authorization further to ensure that Covid-19 patients have effective treatments available.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome